Article excerpt

AT A TIME WHEN drug development should have been spurred by huge increases in R&D expenditures--which increased by more than 50 percent between just 2004 and 2008 (to $65.2 billion)--and by the exploitation of powerful new technologies, drug approvals by the FDA have been disappointing. The 18 new medicines approved in 2007 represent the lowest figure in a quarter century, and the 2008 and 2009 tallies of 24 and 25, respectively, represent scant improvement. Current trends in regulatory policies and requirements will cause further deterioration in drug R&D and approvals.

The imposition of additional regulatory requirements and changes in policy by both the legislative and executive branches of the government will only further increase the time and costs of drug development, diminish competition, and make fewer new products available. The consistently risk-averse Congress has granted the FDA additional powers that place new restrictions on the prescribing, distribution, sale, and advertising of drugs; and at the same time, regulators--especially anti-industry, anti-drug zealots appointed by President Obama--have imposed new criteria in addition to the demonstration of safety and efficacy (which is required by statute) in order to obtain even those limited approvals.

What might be considered an additional, third criterion pertains to the FDA's relatively recent emphasis on the obligations of pharmaceutical company executives to ensure the integrity of the "global manufacturing chain" of their products. In a May 20, 2008, speech, Doug Throgmorton, the deputy director of the FDA's Center for Drug Evaluation and Review, said that controlling the supply chain for quality "is a very complex problem and there are a lot of pieces in place to address," adding that it "starts with the manufacturing sector understanding that there is an expectation on them to provide a manufactured quality product" and emphasizing yet again that "first and foremost" this is an issue of "corporate responsibility."

What sorts of changes do such statements suggest may be required? According to a prominent attorney who was a senior FDA lawyer for many years and is now in private practice, regulators will likely expect to see a more explicit, formal paper trail of control over the supply chain, extending even to third-party certification that each participant in the drug manufacturing chain is performing correctly. The manufacturer and/or marketer of the final product will then have to certify to the FDA that it has verified the entire process. The attorney compared it to the onerous Sarbanes-Oxley assurances of compliance with general business practices. This sort of requirement will add yet another level of complexity (and costs) to drug development.

The FDA has begun to impose what is in effect an additional, fourth criterion for approval of drugs: post-marketing studies as a condition of approval. (Whereas they were once a rarity, they are now required in more than three-quarters of approvals.)

In addition, regulators have created a new fifth criterion that could inflict significant damage on both patients and drug companies: Seemingly arbitrarily, the FDA sometimes requires that new drugs be not merely effective but actually superior to existing therapies, a new standard that is often difficult and extremely costly to meet. In April 2007, the FDA announced what appears to be a landmark decision. Although the law requires that in order to be marketed, a drug must simply be shown to be safe and effective, in denying approval of Merck's new drug, Arcoxia, a COX-2 inhibitor for the relief of arthritis pain, the FDA said that Arcoxia needed to be shown to be superior to existing drugs to merit approval. Robert Meyer, director of the FDA office that oversees arthritis drugs, claimed that the agency's advisory committee had sent a clear message that "simply having another drug on the market ... didn't seem to be sufficient reason" for approval. …